Treatment Improvement With the Use of Innovative Technologies and Robotics in Rehabilitation Process: Observational Longitudinal Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Key performance indicator (KPI) of the room - Number of adverse events
研究概览
简要总结
The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.
The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room.
详细描述
The recovery of motor function is a primary goal for individuals diagnosed with neurological disease, such as Stroke, Parkinson's Disease, Multiple Sclerosis. Various rehabilitation methods have been using in neurorehabilitation hospital, including conventional training and those involving technological devices. Nowadays, the integration of technology into rehabilitation room has been expanding within the National Health System, and their effectiveness in enhancing functionality and quality of life remains a subject of ongoing research in rehabilitation. In addition to rehabilitation devices, such as robotic and virtual reality systems, home automation system may play a crucial role in monitoring and recording patient movements. These sensors can also be employed for home automation in environments such as hospital rehabilitation settings, helping to reduce paid carer hours, quantify the impact of automated data acquisition on the functionality and offer many benefits to people with a disability. Indeed, potentially, the application of home automation system in technological rehabilitation rooms, may allow for the synchronization of environmental data with the patient's clinical history, facilitating the study of functional recovery.
This study is a part of the HosmartAI project (EU Horizon 2020 research and innovation program - grant agreement No 101016834 Pilot #3). The main aim of HoSmartAI project is to develop hospitals based on artificial intelligence (AI) technologies. In Pilot #3, the investigators will integrate data collected by technological devices for motor rehabilitation and home automation sensors installed in room (HosmartAI room) at the Neuromotor Rehabilitation Service of the San Camillo IRCCS Hospital (Venice, Italy). These sensors are able to detect the effective numbers of minutes of therapy, the number of sessions delivered in the room, and detect the presence and falls of the patients. Moreover, all these sensors are managed directly by physiotherapists through an App for smartphone. All data collected will be integrated in a cloud infrastructure, where physiotherapist will check the patients' profile and data collected from clinical assessment and home automation sensors.
In the study, the investigators will enroll patients with neurological disease and motor impairment who are hospitalized in Camillo IRCCS Hospital (Venice, Italy). The treatment (5time/week, for 3 weeks) will consist of 1 hour/day of motor training provided by technological devices (i.e., OAK, VRRS, AMADEO, PABLO) in the HoSmartAI room, in addition to daily 1 hour of conventional motor training. Firstly, the patients will be assessed to define their motor function and personalize the treatment based on their needs, to improve balance, manual dexterity, or upper and lower limb motor recovery. Then, at the end of the treatment, the patients will be assessed using validated clinical scales and questionnaire to determine the clinical effect and patient-reported outcome measurements (i.e., usability, technology acceptability, and user satisfaction).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (> 18 yy)
- •Diagnosis of neurological disease (e.g. ischemic and/or hemorrhagic stroke, Parkinson's, multiple sclerosis, brain trauma, peripheral neuropathy)
排除标准
- •Fractures
- •Major depressive disorder
- •Severe visual and/or hearing impairments
- •Non-pharmacologically controlled epilepsy
- •Severe neglect
- •Severe comprehension deficit
研究组 & 干预措施
HosmartAI training
HosmartAI training will consist of motor training provided by technological devices (i.e. OAK, VRRS, AMADEO, PABLO) in the HoSmartAI room.
干预措施: Technological Motor Rehabilitation (Device)
结局指标
主要结局
Key performance indicator (KPI) of the room - Number of adverse events
时间窗: Every month up to 1 year
Number of adverse events detected in the HoSmartAI room.
Key performance indicator (KPI) of the room - Number of physiotherapists involved
时间窗: Every month up to 1 year
Number of physiotherapists involved inside the HoSmartAI room.
Key performance indicator (KPI) of the room - Number of treatments
时间窗: Every month up to 1 year
Number of treatments that are provided inside the HoSmartAI room.
Key performance indicator (KPI) ot the room - Number of sessions
时间窗: Every month up to 1 year
Number of sessions that are provided inside the HoSmartAI room.
Room Key performance indicator (KPI) of the room - Number of minutes of therapy
时间窗: Every month up to 1 year
Number of minutes of therapy that are provided inside the HoSmartAI room.
次要结局
- Berg balance scale (BBS)(Change from Baseline BBS at 3 weeks)
- Nine Hole Pegboard Test(Change from Baseline Nine Hole Pegboard Test at 3 weeks)
- Reaching Performance Scale(Change from Baseline Reaching Performance Scale at 3 weeks)
- Trunk Control Test (TCT)(Change from Baseline TCT at 3 weeks)
- Box and Blocks Test(Change from Baseline Box and Blocks Test at 3 weeks)
- 10 Meter Walk Test (10MWT)(Change from Baseline 10MWT at 3 weeks)
- Functional Ambulation Categories (FAC)(Change from Baseline FAC at 3 weeks)
- Number of falls(Require multiple time points before the training to obtain the value (i.e.,12 months, 3 weeks))
- EuroQol questionnaire (EQ-5D)(Change from Baseline EQ-5D at 3 weeks)
- Short Form Patient Satisfaction Questionnaire (PSQ-18)(Change from Baseline PSQ-18 at 3 weeks)
- System Usability Scale (SUS)(Change from Baseline SUS at 3 weeks)
- User Experience Questionnaire (UEQ)(Change from Baseline UEQ at 3 weeks)